Sciatic Nerve Block With ALX006 in Subjects Undergoing Bunionectomy

NCT07574385 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: RBL-201
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 2, randomized, double-blind, active-controlled, dose-escalation study evaluating the safety, pharmacokinetics, efficacy, and pharmacodynamics of ALX006, an extended-release bupivacaine formulation, administered as a single-dose sciatic nerve block in the popliteal fossa in adult subjects undergoing primary unilateral bunionectomy. Approximately 60 subjects will be enrolled across 3 sequential dose cohorts (100 mg, 150 mg, 200 mg ALX006), with each cohort comparing ALX006 against MARCAINE 0.25% (bupivacaine HCl 50 mg) as the active comparator at a 3:1 randomization ratio. Dose escalation between cohorts is governed by an Independent Data Monitoring Committee.

Conditions

Hallux Valgus; Bunionectomy

Keywords

ALX006; Bupivacaine; Popliteal fossa nerve block; Analgesia; Post-operative analgesia

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of treatment-emergent adverse events (TEAEs)

  TEAEs graded by CTCAE v5.0, summarized by System Organ Class and Preferred Term

  From start of nerve block procedure through 360 Hour Visit (Day 15)

Secondary Outcomes (14)

• AUC of NRS pain intensity scores 0-72 hours post-surgery

  0 to 72 hours post-surgery

• AUC of NRS pain intensity scores 0-96 hours post-surgery

  0 to 96 hours post-surgery

• AUC of NRS pain intensity scores 0-120 hours post-surgery

  0 to 120 hours post-surgery

• Total postsurgical opioid consumption in oral morphine equivalents (OMED) from 0 to 72 hours post-surgery

  0 to 72 hours post-surgery

• Total postsurgical opioid consumption in oral morphine equivalents (OMED) from 0 to 96 hours post-surgery

  0 to 96 hours post-surgery

Other Outcomes (4)

• Median time to onset of sensory block

  From end of block administration through 168 hours

• Median duration of sensory block

  From end of block administration through 168 hours

• Median time to onset of motor block

  From end of block administration through 168 hours

Study Arms (4)

ALX006 100 mg

EXPERIMENTAL

Single-dose ALX006 100 mg (50 mg/mL bupivacaine free base) administered as ultrasound-guided sciatic nerve block in the popliteal fossa, 60 min (±15 min) prior to bunionectomy.

Drug: ALX006 (bupivacaine extended-release injection); Procedure: Sciatic Nerve Block

ALX006 150 mg

EXPERIMENTAL

Single-dose ALX006 150 mg (50 mg/mL bupivacaine free base) administered as ultrasound-guided sciatic nerve block in the popliteal fossa, 60 min (±15 min) prior to bunionectomy.

Drug: ALX006 (bupivacaine extended-release injection); Procedure: Sciatic Nerve Block

ALX006 200 mg

EXPERIMENTAL

Single-dose ALX006 200 mg (50 mg/mL; bupivacaine free base) administered as ultrasound-guided sciatic nerve block in the popliteal fossa, 60 min (±15 min) prior to bunionectomy.

Drug: ALX006 (bupivacaine extended-release injection); Procedure: Sciatic Nerve Block

MARCAINE 0.25%

ACTIVE COMPARATOR

Single-dose MARCAINE 0.25% (bupivacaine HCl 50 mg; 20 mL), administered as ultrasound-guided sciatic nerve block in the popliteal fossa, 60 min (±15 min) prior to bunionectomy.

Drug: Bupivacaine Hcl 0.25% Inj; Procedure: Sciatic Nerve Block

Interventions

ALX006 (bupivacaine extended-release injection) DRUG

ALX006 (50 mg/mL bupivacaine free base)

ALX006 100 mg; ALX006 150 mg; ALX006 200 mg

Bupivacaine Hcl 0.25% Inj DRUG

Bupivacaine HCl 0.25% plain (2.5 mg/mL)

Also known as: MARCAINE 0.25%

MARCAINE 0.25%

Sciatic Nerve Block PROCEDURE

Sciatic nerve block in the popliteal fossa

Also known as: Sciatic Nerve Block in the Popliteal Fossa

ALX006 100 mg; ALX006 150 mg; ALX006 200 mg; MARCAINE 0.25%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, ages 18 or older at screening
• American Society of Anesthesiologists (ASA) physical status 1, 2, or 3 (see Appendix 5)
• Able to provide informed consent, adhere to the study schedule, and complete all study assessments
• Primary surgical indication is related to a bunion deformity (i.e., hallux valgus) and subject is scheduled to undergo a primary unilateral distal metaphyseal osteotomy procedure (i.e., Austin procedure)
• Indicated to undergo elective (i.e., not emergency) bunionectomy
• Body Mass Index (BMI) ≥18 and \<40 kg/m2

You may not qualify if:

• Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine HCl, NSAIDs)
• Concurrent painful physical condition (e.g. arthritis, fibromyalgia, cancer) that may require analgesic treatment with NSAIDs or opioids in the post dosing period for pain that is not strictly related to the surgery and which, in the Investigator's opinion, may confound the post dosing assessments
• Inadequate sensory function of the foot/ankle as assessed by the Investigator
• History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past two (2) years
• Administration of an investigational drug within thirty (30) days or five (5) elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
• Administration of any local anesthetic within 72 hours prior to administration of study drug, other than for pretreatment prior to a needle placement
• Require additional local anesthetic other than study drug or lidocaine used for the Mayo field block or for pretreatment prior to a needle placement during the study period
• Uncontrolled anxiety, psychiatric, or neurological disorder that, in the opinion of the Investigator, could interfere with study assessments or compliance
• Currently pregnant, nursing, or planning to become pregnant during the study
• Clinically significant medical disease that, in the opinion of the Investigator would make participation in a clinical study inappropriate. This includes diabetic neuropathy, coagulation or bleeding disorders, severe peripheral vascular disease, renal insufficiency, hepatic dysfunction, glucose-6-phosphate dehydrogenase deficiency or other conditions that would constitute a contraindication to participation in the study
• Confirmed clinically significant vital sign or ECG abnormality, including QTcF \> 450 msec at Screening
• Has any of the following laboratory abnormalities during Screening (1 retest permitted):
• History of liver cirrhosis, having an aspartate aminotransferase \>3x the upper limit of normal (ULN), or having an alanine aminotransferase \> 3x ULN.
• Severe kidney function impairment as defined by estimated glomerular filtration rate (eGFR) by CKD-EPI 2021 equation \<30 mL/min/1.73 m²or on dialysis.
• Platelet count \< 100,000/uL, hemoglobin \< 12 g/dL, or hematocrit \< 35%.

Sponsors & Collaborators

• Rebel Medicine Inc: lead

Study Sites (1)

CenExel Salt Lake City

Millcreek, Utah, 84107, United States

RECRUITING

MeSH Terms

Conditions

Hallux Valgus; Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jayant Agarwal, MD

  Rebel Medicine Inc

  STUDY DIRECTOR

Central Study Contacts

Caleb Lade, MD

CONTACT

918-808-8399; caleb.lade@rebelmedicine.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 7, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)